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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00426803
  Purpose

This trial is conducted in North America, Europe, Asia and Oceania.

The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.


Condition Intervention Phase
Spontaneous Intracerebral Haemorrhage
Drug: Recombinant Factor VIIa
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Efficacy and Safety of Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Reducing haematoma growth

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome after 3 months

Estimated Enrollment:   400
Study Start Date:   August 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426803

Show 36 study locations  Show 36 Study Locations

Sponsors and Collaborators
Novo Nordisk
  More Information

Study ID Numbers:   F7ICH-1371
First Received:   January 24, 2007
Last Updated:   January 26, 2007
ClinicalTrials.gov Identifier:   NCT00426803
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Cerebral Hemorrhage
Vascular Diseases
Central Nervous System Diseases
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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